BR112017010166A2 - solid tumor treatment method, activity inhibition method, oral dosage form for treating a solid tumor, solid pharmaceutical formulation, process for preparing a pharmaceutical formulation, and solid pharmaceutical composition - Google Patents

solid tumor treatment method, activity inhibition method, oral dosage form for treating a solid tumor, solid pharmaceutical formulation, process for preparing a pharmaceutical formulation, and solid pharmaceutical composition

Info

Publication number
BR112017010166A2
BR112017010166A2 BR112017010166-1A BR112017010166A BR112017010166A2 BR 112017010166 A2 BR112017010166 A2 BR 112017010166A2 BR 112017010166 A BR112017010166 A BR 112017010166A BR 112017010166 A2 BR112017010166 A2 BR 112017010166A2
Authority
BR
Brazil
Prior art keywords
effective amount
therapeutically effective
dosage form
epz
dissolution
Prior art date
Application number
BR112017010166-1A
Other languages
English (en)
Portuguese (pt)
Inventor
Keilhack Heike
Truitt Brett
Suzuki Yuta
Murase Tsukasa
Shikata Futoshi
Original Assignee
Epizyme, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Epizyme, Inc. filed Critical Epizyme, Inc.
Publication of BR112017010166A2 publication Critical patent/BR112017010166A2/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/535—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one oxygen as the ring hetero atoms, e.g. 1,2-oxazines
    • A61K31/5375—1,4-Oxazines, e.g. morpholine
    • A61K31/5377—1,4-Oxazines, e.g. morpholine not condensed and containing further heterocyclic rings, e.g. timolol
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2095—Tabletting processes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
    • A61K9/2846—Poly(meth)acrylates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2893—Tablet coating processes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Plural Heterocyclic Compounds (AREA)
  • Steroid Compounds (AREA)
BR112017010166-1A 2014-11-17 2015-11-17 solid tumor treatment method, activity inhibition method, oral dosage form for treating a solid tumor, solid pharmaceutical formulation, process for preparing a pharmaceutical formulation, and solid pharmaceutical composition BR112017010166A2 (en)

Applications Claiming Priority (7)

Application Number Priority Date Filing Date Title
US201462080985P 2014-11-17 2014-11-17
US62/080,985 2014-11-17
US201562166572P 2015-05-26 2015-05-26
US62/166,572 2015-05-26
US201562251903P 2015-11-06 2015-11-06
US62/251,903 2015-11-06
PCT/US2015/061194 WO2016081523A1 (en) 2014-11-17 2015-11-17 Method for treating cancer

Publications (1)

Publication Number Publication Date
BR112017010166A2 true BR112017010166A2 (en) 2018-02-14

Family

ID=56014476

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112017010166-1A BR112017010166A2 (en) 2014-11-17 2015-11-17 solid tumor treatment method, activity inhibition method, oral dosage form for treating a solid tumor, solid pharmaceutical formulation, process for preparing a pharmaceutical formulation, and solid pharmaceutical composition

Country Status (20)

Country Link
US (3) US10786511B2 (https=)
EP (2) EP3220916B1 (https=)
JP (3) JP6829684B2 (https=)
KR (3) KR20240035908A (https=)
CN (2) CN107249591B (https=)
AU (3) AU2015350108B2 (https=)
BR (1) BR112017010166A2 (https=)
DK (1) DK3220916T3 (https=)
EA (1) EA201791095A1 (https=)
ES (1) ES2947819T3 (https=)
FI (1) FI3220916T3 (https=)
HU (1) HUE062159T2 (https=)
IL (4) IL296080B2 (https=)
LT (1) LT3220916T (https=)
MX (2) MX383484B (https=)
PL (1) PL3220916T3 (https=)
PT (1) PT3220916T (https=)
SG (1) SG11201703806XA (https=)
SI (1) SI3220916T1 (https=)
WO (1) WO2016081523A1 (https=)

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Publication number Priority date Publication date Assignee Title
JO3363B1 (ar) 2011-04-13 2019-03-13 Epizyme Inc مركبات بنزين مستبدلة بأريل أو أريل غير متجانس
CA2887243C (en) 2012-10-15 2024-04-09 Epizyme, Inc. Methods of treating cancer
CA2931263A1 (en) 2013-12-06 2015-06-11 Epizyme, Inc. Combination therapy for treating cancer
IL285201B2 (en) 2014-06-17 2024-05-01 Epizyme Inc EZH2 inhibitors for the treatment of lymphoma
HUE062159T2 (hu) * 2014-11-17 2023-10-28 Epizyme Inc Módszer a rák kezelésére N-((4,6-dimetil-2-oxo-l,2-dihidropiridin-3-il)metil)-5-(etil(tetrahidro-2H -pirán-4-il)amino)-4-metil-4'-(morfolinmetil)-[1,1'-bifenil]-3-karboxamiddal
CN108135908A (zh) 2015-04-20 2018-06-08 Epizyme股份有限公司 用于治疗癌症的组合疗法
EP3307713A4 (en) 2015-06-10 2019-01-23 Epizyme, Inc. EZH2 INHIBITOR FOR THE TREATMENT OF LYMPHOMA
KR20180042356A (ko) 2015-08-24 2018-04-25 에피자임, 인코포레이티드 암 치료 방법
WO2017132518A1 (en) 2016-01-29 2017-08-03 Epizyme, Inc. Combination therapy for treating cancer
WO2017210395A1 (en) 2016-06-01 2017-12-07 Epizyme, Inc. Use of ezh2 inhibitors for treating cancer
EP3471830A4 (en) 2016-06-17 2020-02-26 Epizyme Inc EZH2 INHIBITORS TO TREAT CANCER
TW201831181A (zh) 2017-01-19 2018-09-01 日商第一三共股份有限公司 用以用於治療ｈｔｌｖ－１相關脊髓病之醫藥組成物
US11642346B2 (en) 2017-03-31 2023-05-09 Epizyme, Inc. Combination therapy for treating cancer
EP3630080A4 (en) 2017-06-02 2021-03-10 Epizyme, Inc. USE OF EZH2 INHIBITORS TO TREAT CANCER
WO2019050924A1 (en) 2017-09-05 2019-03-14 Epizyme, Inc. POLY THERAPY FOR THE TREATMENT OF CANCER
KR20220130698A (ko) * 2019-12-20 2022-09-27 에피자임, 인코포레이티드 Ezh2 억제제의 결정질 하이드로브로마이드 염, 이의 제조 및 암의 치료에 유용한 약학적 조성물
JP7628876B2 (ja) 2021-04-23 2025-02-12 日立Astemo株式会社 情報処理装置、情報処理方法、プログラムおよび記憶媒体
US20250146080A1 (en) * 2022-02-17 2025-05-08 Memorial Sloan-Kettering Cancer Center Methods for overcoming tazemetostat-resistance in cancer patients
EP4514391A1 (en) 2022-04-27 2025-03-05 Daiichi Sankyo Company, Limited Combination of antibody-drug conjugate with ezh1 and/or ezh2 inhibitor

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US6248363B1 (en) * 1999-11-23 2001-06-19 Lipocine, Inc. Solid carriers for improved delivery of active ingredients in pharmaceutical compositions
US7229774B2 (en) 2001-08-02 2007-06-12 Regents Of The University Of Michigan Expression profile of prostate cancer
US20070026064A1 (en) * 2005-07-29 2007-02-01 Yoder Steven L Pharmaceutical dosage forms having watermark-type identification and authentication inditia
WO2008121476A1 (en) * 2007-03-28 2008-10-09 Tapestry Pharmaceuticals, Inc. Biologically active taxane analogs and methods of treatment by oral administration
US20100278921A1 (en) * 2009-04-30 2010-11-04 Fischer Cristina M Solid oral formulation of abt-263
US9175331B2 (en) 2010-09-10 2015-11-03 Epizyme, Inc. Inhibitors of human EZH2, and methods of use thereof
BR112013005806B1 (pt) 2010-09-10 2022-05-10 Epizyme, Inc Métodos para detectar se um indivíduo é um candidato para o tratamento com ou responsivo a um inibidor de ezh2 e usos terapêuticos do dito inibidor de ezh2
WO2012097222A1 (en) * 2011-01-14 2012-07-19 Bristol-Myers Squibb Company High drug load tablet formulation of brivanib alaninate
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RU2704445C2 (ru) 2012-03-12 2019-10-28 Эпизайм, Инк. Ингибиторы ezh2 человека и способы их применения
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KR102142177B1 (ko) * 2013-10-16 2020-08-07 에피자임, 인코포레이티드 Ezh2 억제용 하이드로클로라이드 염 형태
EP3057594A4 (en) * 2013-10-18 2017-06-07 Epizyme, Inc. Method of treating cancer
CA2931263A1 (en) 2013-12-06 2015-06-11 Epizyme, Inc. Combination therapy for treating cancer
IL285201B2 (en) * 2014-06-17 2024-05-01 Epizyme Inc EZH2 inhibitors for the treatment of lymphoma
US20170217941A1 (en) 2014-06-25 2017-08-03 Epizyme, Inc. Substituted benzene and 6,5-fused bicyclic heteroaryl compounds
IL310279A (en) 2014-10-16 2024-03-01 Epizyme Inc Method for treating cancer
HUE062159T2 (hu) 2014-11-17 2023-10-28 Epizyme Inc Módszer a rák kezelésére N-((4,6-dimetil-2-oxo-l,2-dihidropiridin-3-il)metil)-5-(etil(tetrahidro-2H -pirán-4-il)amino)-4-metil-4'-(morfolinmetil)-[1,1'-bifenil]-3-karboxamiddal
EP3307713A4 (en) * 2015-06-10 2019-01-23 Epizyme, Inc. EZH2 INHIBITOR FOR THE TREATMENT OF LYMPHOMA
EP3471830A4 (en) * 2016-06-17 2020-02-26 Epizyme Inc EZH2 INHIBITORS TO TREAT CANCER

Also Published As

Publication number Publication date
US12168014B2 (en) 2024-12-17
IL252182B2 (en) 2023-02-01
MX2021006734A (es) 2021-07-02
AU2024201171A1 (en) 2024-03-14
IL296080A (en) 2022-11-01
IL304252A (en) 2023-09-01
CN107249591A (zh) 2017-10-13
CN116650500A (zh) 2023-08-29
PL3220916T3 (pl) 2023-08-14
EA201791095A1 (ru) 2017-10-31
IL296080B1 (en) 2023-08-01
NZ768247A (en) 2024-05-31
IL252182B (en) 2022-10-01
SG11201703806XA (en) 2017-06-29
IL304252B1 (en) 2025-11-01
KR102644844B1 (ko) 2024-03-07
ES2947819T3 (es) 2023-08-21
CN116650500B (zh) 2026-03-06
US20170360797A1 (en) 2017-12-21
PT3220916T (pt) 2023-06-26
JP2017537899A (ja) 2017-12-21
DK3220916T3 (da) 2023-06-26
US10786511B2 (en) 2020-09-29
EP4272742A1 (en) 2023-11-08
EP3220916B1 (en) 2023-04-19
KR20240035908A (ko) 2024-03-18
HUE062159T2 (hu) 2023-10-28
JP7485810B2 (ja) 2024-05-16
MX383484B (es) 2025-03-11
CN107249591B (zh) 2024-01-30
KR20170103768A (ko) 2017-09-13
IL252182A0 (en) 2017-07-31
JP6829684B2 (ja) 2021-02-10
KR102338802B1 (ko) 2021-12-14
EP3220916A4 (en) 2018-07-11
SI3220916T1 (sl) 2023-09-29
EP3220916A1 (en) 2017-09-27
JP2021073241A (ja) 2021-05-13
FI3220916T3 (fi) 2023-06-19
AU2015350108B2 (en) 2021-04-08
KR20210156840A (ko) 2021-12-27
US20250064822A1 (en) 2025-02-27
AU2021204706B2 (en) 2023-11-23
NZ731696A (en) 2024-03-22
AU2015350108A1 (en) 2017-05-25
WO2016081523A1 (en) 2016-05-26
MX2017006089A (es) 2017-12-11
JP2023062189A (ja) 2023-05-02
AU2021204706A1 (en) 2021-07-29
LT3220916T (lt) 2023-07-25
US20210060030A1 (en) 2021-03-04
IL323396A (en) 2025-11-01
IL296080B2 (en) 2023-12-01
CA2967664A1 (en) 2016-05-26
IL304252B2 (en) 2026-03-01
AU2024201171B2 (en) 2026-01-29

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B07D Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette]

Free format text: DE ACORDO COM O ARTIGO 229-C DA LEI NO 10196/2001, QUE MODIFICOU A LEI NO 9279/96, A CONCESSAO DA PATENTE ESTA CONDICIONADA A ANUENCIA PREVIA DA ANVISA. CONSIDERANDO A APROVACAO DOS TERMOS DO PARECER NO 337/PGF/EA/2010, BEM COMO A PORTARIA INTERMINISTERIAL NO 1065 DE 24/05/2012, ENCAMINHA-SE O PRESENTE PEDIDO PARA AS PROVIDENCIAS CABIVEIS.

B07E Notification of approval relating to section 229 industrial property law [chapter 7.5 patent gazette]
B06U Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]
B07A Application suspended after technical examination (opinion) [chapter 7.1 patent gazette]
B09B Patent application refused [chapter 9.2 patent gazette]
B12B Appeal against refusal [chapter 12.2 patent gazette]